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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name mask, oxygen
510(k) Number K852629
Device Name AERO-MASK TWO
Applicant
ASHAI CO. LTD.
620 HARRIS ST.
ULTIMO, N.S.W. 2007
AUSTRALIA,  AU
Applicant Contact KALNIN
Correspondent
ASHAI CO. LTD.
620 HARRIS ST.
ULTIMO, N.S.W. 2007
AUSTRALIA,  AU
Correspondent Contact KALNIN
Regulation Number868.5580
Classification Product Code
BYG  
Date Received06/20/1985
Decision Date 09/18/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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